bioAffinity’s CyPath® Lung Cancer Test Supported by Newly Published Flow Cytometry Guidelines
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) announced that its VP of Diagnostics, Jennifer Rebeles, Ph.D., contributed to a peer-reviewed paper on flow cytometry guidelines for rare matrix samples. The paper, published in Cytometry Part B: Clinical Cytometry, supports the validation approach used for bioAffinity's CyPath® Lung cancer test.
CyPath® Lung is a noninvasive test for early lung cancer detection, particularly useful for patients with pulmonary nodules. It has shown 92% sensitivity and 87% specificity in detecting lung cancer in nodules 20mm or less. The new guidelines address challenges in validating unique sample types like sputum, which CyPath® Lung uses.
The paper supplements the CLSI Guideline H62 and reflects the increasing use of specialized samples in flow cytometry. It acknowledges the challenges bioAffinity scientists overcame in developing CyPath® Lung, including dealing with high viscosity, inhibitors, and complex cellular mixtures.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) ha annunciato che il suo VP di Diagnostica, Jennifer Rebeles, Ph.D., ha contribuito a un articolo sottoposto a peer review sulle linee guida per la citometria a flusso per campioni rari. L'articolo, pubblicato su Cytometry Part B: Clinical Cytometry, supporta l'approccio di validazione utilizzato per il test sul cancro CyPath® Lung di bioAffinity.
CyPath® Lung è un test non invasivo per la rilevazione precoce del cancro ai polmoni, particolarmente utile per i pazienti con noduli polmonari. Ha mostrato 92% di sensibilità e 87% di specificità nel rilevare il cancro ai polmoni in noduli di 20mm o meno. Le nuove linee guida affrontano le sfide nella validazione di tipi di campioni unici come l'espettorato, che CyPath® Lung utilizza.
L'articolo integra la linea guida CLSI H62 e riflette l'uso crescente di campioni specializzati nella citometria a flusso. Riconosce le sfide superate dagli scienziati di bioAffinity nello sviluppo di CyPath® Lung, inclusa la gestione di alta viscosità, inibitori e miscele cellulari complesse.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) anunció que su VP de Diagnósticos, Jennifer Rebeles, Ph.D., contribuyó a un artículo revisado por pares sobre las pautas de citometría de flujo para muestras raras. El artículo, publicado en Cytometry Part B: Clinical Cytometry, apoya el enfoque de validación utilizado para la prueba de cáncer CyPath® Lung de bioAffinity.
CyPath® Lung es un test no invasivo para la detección temprana del cáncer de pulmón, particularmente útil para pacientes con nódulos pulmonares. Ha mostrado 92% de sensibilidad y 87% de especificidad en la detección del cáncer de pulmón en nódulos de 20 mm o menos. Las nuevas pautas abordan los desafíos en la validación de tipos de muestras únicos como el esputo, que utiliza CyPath® Lung.
El artículo complementa la Directriz CLSI H62 y refleja el uso creciente de muestras especializadas en la citometría de flujo. Reconoce los desafíos que los científicos de bioAffinity superaron en el desarrollo de CyPath® Lung, incluida la gestión de alta viscosidad, inhibidores y mezclas celulares complejas.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW)는 진단 부서副사장 제니퍼 레벨리스(Jennifer Rebeles) 박사가 희귀 매트릭스 샘플에 대한 유세포 분석 가이드라인에 대한 동료 리뷰 논문에 기여했다고 발표했습니다. 이 논문은 Cytometry Part B: Clinical Cytometry에 게재되었으며 bioAffinity의 CyPath® Lung 암 검사에 사용되는 검증 접근 방식을 지원합니다.
CyPath® Lung은 조기 폐암 발견을 위한 비침습적 검사로, 폐 결절이 있는 환자에게 특히 유용합니다. 20mm 이하의 결절에서 폐암을 발견하는 데 92%의 민감도와 87%의 특이도를 보여주었습니다. 새로운 가이드라인은 CyPath® Lung에서 사용하는 가래와 같은 독특한 샘플 유형의 검증에서의 문제를 다루고 있습니다.
이 논문은 CLSI 가이드라인 H62를 보완하며 유세포 분석에서 전문 샘플의 사용이 증가하고 있음을 반영합니다. CyPath® Lung 개발 과정에서 bioAffinity 과학자들이 극복한 높은 점도, 억제제 및 복합 세포 혼합물 다루기와 같은 문제들을 인정합니다.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) a annoncé que sa VP des diagnostics, Jennifer Rebeles, Ph.D., a contribué à un article évalué par des pairs sur les directives de cytométrie en flux pour des échantillons de matrice rares. L'article, publié dans Cytometry Part B: Clinical Cytometry, soutient l'approche de validation utilisée pour le test de cancer CyPath® Lung de bioAffinity.
CyPath® Lung est un test non invasif pour la détection précoce du cancer du poumon, particulièrement utile pour les patients présentant des nodules pulmonaires. Il a montré 92 % de sensibilité et 87 % de spécificité dans la détection du cancer du poumon dans les nodules de 20 mm ou moins. Les nouvelles lignes directrices abordent les défis de la validation de types d'échantillons uniques tels que les crachats, que CyPath® Lung utilise.
L'article complète la directive CLSI H62 et reflète l'utilisation croissante d'échantillons spécialisés en cytométrie en flux. Il reconnaît les défis que les scientifiques de bioAffinity ont surmontés dans le développement de CyPath® Lung, y compris la gestion de haute viscosité, les inhibiteurs et les mélanges cellulaires complexes.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) gab bekannt, dass die VP für Diagnostik, Jennifer Rebeles, Ph.D., zu einem von Experten begutachteten Artikel über die Richtlinien zur Durchflusszytometrie für seltene Matrixproben beigetragen hat. Der Artikel, veröffentlicht in Cytometry Part B: Clinical Cytometry, unterstützt den Validierungsansatz, der für den CyPath® Lung Krebs-Test von bioAffinity verwendet wird.
CyPath® Lung ist ein nicht-invasiver Test zur frühen Lungenkrebsdiagnose, der insbesondere für Patienten mit pulmonalen Knoten nützlich ist. Er hat eine 92%ige Sensitivität und 87%ige Spezifität bei der Erkennung von Lungenkrebs in Knoten von 20 mm oder weniger gezeigt. Die neuen Richtlinien beschäftigen sich mit den Herausforderungen bei der Validierung einzigartiger Probenarten wie Sputum, die von CyPath® Lung verwendet werden.
Der Artikel ergänzt die CLSI-Richtlinie H62 und spiegelt die zunehmende Verwendung von spezialisierten Proben in der Durchflusszytometrie wider. Es anerkennt die Herausforderungen, die die Wissenschaftler von bioAffinity bei der Entwicklung von CyPath® Lung überwunden haben, einschließlich der Handhabung von hoher Viskosität, Inhibitoren und komplexen Zellmischungen.
- CyPath® Lung test shows 92% sensitivity and 87% specificity in detecting lung cancer for nodules 20mm or less
- New flow cytometry guidelines support bioAffinity's validation approach for CyPath® Lung
- bioAffinity's VP of Diagnostics contributed to influential peer-reviewed paper on flow cytometry guidelines
- None.
bioAffinity VP served on expert panel that published new guidance
“Our CyPath® Lung noninvasive test for the early detection of lung cancer is a novel test that uses sputum, a unique sample type that is not typically used in clinical flow cytometry assays,” Rebeles said. Flow cytometry is a well-established technology used in both research and clinical practice because of its ability to rapidly measure physical and chemical properties of cells in biological samples.
The paper supplements the Clinical and Laboratory Standards Institute (CLSI) Guideline H62, the standard for validating assays performed by flow cytometry issued in 2021, by addressing challenges and considerations in validation with unique sample types.
“The new guidelines support the way we have validated the CyPath® Lung assay in our own laboratory, including customized protocols, specialized reagents, optimized cytometer settings and unique gating strategies,” Rebeles added.
CyPath® Lung fulfills the need for a noninvasive test for the early detection of lung cancer and is especially useful for patients whose lung cancer screening or other scan reveals a pulmonary nodule. CyPath® Lung has shown
Rebeles was one of 12 subject matter experts from industry, government and healthcare professions who participated in CLSI’s consensus process to provide best practices to expand the scope of the H62 guidelines beyond the use of flow cytometry to analyze common biological samples to include specialized samples like sputum.
The updated guidelines reflect the increasing use of specialized or unconventional samples in flow cytometry. The paper acknowledges some of the challenges bioAffinity scientists overcame when developing the CyPath® Lung test. The paper notes, “Factors such as high viscosity, presence of inhibitors, cellular debris or other artifacts, complex cellular mixtures, or unique tissue and cellular morphology might necessitate adjustments to standard flow cytometry techniques to achieve accurate and reliable results.”
“It is gratifying to see our workgroup’s recommendations shared with the clinical cytometry community. The panel’s work acknowledges and encourages the validation of rare matrices in flow cytometry for clinical use,” Rebeles said.
About CyPath® Lung
CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had
About bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW)
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com and follow us on LinkedIn, Facebook and X.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the high viscosity, presence of inhibitors, cellular debris or other artifacts, complex cellular mixtures, or unique tissue and cellular morphology necessitating adjustments to standard flow cytometry techniques to achieve accurate and reliable results and acknowledging and encouraging the validation of rare matrices in flow cytometry for clinical use. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241016968586/en/
bioAffinity Technologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
Investor Relations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498
BIAF@redchip.com
Source: bioAffinity Technologies, Inc.
FAQ
What is the sensitivity and specificity of bioAffinity's CyPath® Lung test for detecting lung cancer (BIAF)?
How does the new flow cytometry guideline impact bioAffinity's CyPath® Lung test (BIAF)?
What type of sample does bioAffinity's CyPath® Lung test use for lung cancer detection (BIAF)?
Who from bioAffinity Technologies contributed to the new flow cytometry guidelines (BIAF)?
